Reporting An Adverse Event

WHAT IS AN ADVERSE EVENT?

An adverse event is any unintended harm that occurs as a result of a health treatment. A side-effect or complication may include symptoms or harm that is expected to occur in a percentage of patients but even if it is, the problem should be reported to ensure that it is not occurring at an unacceptably high rate.

WHY REPORT AN ADVERSE EVENT?

All health care involves some risk so it is important to know what the risks are and how likely they are to occur before you agree to have the treatment. The reason reporting a suspected adverse event to the relevant authority can help minimise the risk to others is because:

It may identify side-effects or complications that were not expected in relation to a specific treatment which make the treatment unsafe, or

It may identify a side-effect or complication that may have been expected to occur at a certain rate, but is in fact occurring at a much higher rate making the treatment relatively unsafe.

WHO SHOULD YOU REPORT AN ADVERSE EVENT TO?

If you suspect that you are suffering from side-effects or complications from a treatment the most important thing to do first is to seek medical help and report the symptoms to your doctor so that the harm and risk to your own health is minimised.

In a perfect world you would be able to report all adverse vents to a single authority. Unfortunately in the real world there is a range of authorities and to make sure your report counts you have to make sure that it gets to the right organisation and that depends on what type of problem you have experienced.

Therapeutic products including medicines and medical devices. If the problem is in relation to a therapeutic product, like a medical device (e.g. a device that is implanted or a piece of medical equipment like an insulin pump) or medicine you can report the event directly to the Therapeutic Goods Administration (TGA). The TGA will record reports of known complications and side-effects on their database to ensure that known complications are not occurring at an unacceptably high rate and also to detect complications which haven't been reported before. Alternatively if the problem involves a medicine you can report it to the Adverse Medicine Events Line (1300 134 237). The Adverse Medicine Events Line provides an opportunity for consumers to consult with a pharmacist about medicine safety and ensures that adverse experiences with medicine are taken seriously and reported to the relevant authority.

Services provided in a hospital. If the problem involves services provided at a hospital you can make a report directly to the individual hospital's Complaints Officer before or after you leave the hospital. Hospitals are required to report to their state health department data about the complaints that they receive. If you don't receive a satisfactory response from the hospital then you can make a complaint to the Health Ombudsman in your state.

Services provided by a doctor or other practitioner. If the problem involves a medical service provided in the community by a doctor or other health practitioner such as a dentist, chiropractor, psychologist or nurse, then you can make a report to your health complaints commissioner or equivalent medical board. If you don't receive an adequate response you can make a complaint to the registration board – which is now a national body called the Australian Health Practitioners' Registration Authority.

HOW CAN YOU MAKE SURE YOUR REPORT HAS BEEN ADEQUATELY INVESTIGATED?

When you make a complaint ask to be informed of any action taken in relation to your complaint. Depending on the type and seriousness of the side-effect or complication you are reporting different levels of investigation should be undertaken. In general authorities will conduct a more thorough investigation if:

the report involves actual or potential significant injury or harm

similar reports have been received by a number of people which suggests that the side-effect or complication is occurring at an unexpectedly high rate